HealthyPhase 1NCT03609775
A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
A Phase 1 study testing ACT-541468 and Ethanol 10% in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACT-541468 and Ethanol 10%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Aug 2018to 9 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent prior to any study-mandated procedure.
- Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a reliable method of contraception, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential (i.e., postmenopausal).
- Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests.
- Previous experience with alcohol consumption and, therefore, familiar with the effects of alcohol.
Who cannot join
- Pregnant or lactating women.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- Nicotine intake within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
- History or clinical evidence of alcoholism or drug abuse.
Show all 9Show fewer
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females).
- Individuals of Asian descent or other individuals reporting ethanol intolerance.
- Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects
- Conditions
- Healthy
- Being tested
- ACT-541468, ACT-541468 placebo, Ethanol 10%, Ethanol placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-541468Drug
One tablet of 50 mg ACT-541468 will be administered orally.
ACT-541468 placeboOther
Matching ACT-541468 placebo will be administered orally as 1 tablet.
Ethanol 10%Other
Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.
Ethanol placeboOther
Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (ethanol + ACT-541468) | Experimental | 5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg) Receives: Drug: ACT-541468; Other: Ethanol 10% |
| Treatment B (ethanol placebo + ACT-541468) | Experimental | 5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg) Receives: Drug: ACT-541468; Other: Ethanol placebo |
| Treatment C (ethanol + ACT-541468 placebo) | Experimental | 5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo Receives: Other: ACT-541468 placebo; Other: Ethanol 10% |
| Treatment D (ethanol placebo + ACT-541468 placebo) | Experimental | 5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo Receives: Other: ACT-541468 placebo; Other: Ethanol placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation
Measured: Several timepoints on Day 1; for up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start28 Aug 2018
- Primary completion9 Oct 2018
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-dummy, four-way crossover study design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascale Gasser, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609775
- Sponsor's protocol ID
- ID-078-111
- Status last verified
- Oct 2018
- First submitted
- 25 Jul 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berger B, Brooks S, Zuiker R, Richard M, Muehlan C, Dingemanse J. Pharmacological Interactions between the Dual Orexin Receptor Antagonist Daridorexant and Ethanol in a Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Four-Way Crossover Phase I Study in Healthy Subjects. CNS Drugs. 2020 Dec;34(12):1253-1266. doi: 10.1007/s40263-020-00768-8. Epub 2020 Nov 18.
PubMed 33205362
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03609775
- Acronym / sponsor ID
- ID-078-111
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-dummy, four-way crossover study design
| Arm | Type | Receives |
|---|---|---|
| Treatment A (ethanol + ACT-541468) | Experimental | Drug: ACT-541468, Other: Ethanol 10%5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg) |
| Treatment B (ethanol placebo + ACT-541468) | Experimental | Drug: ACT-541468, Other: Ethanol placebo5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg) |
| Treatment C (ethanol + ACT-541468 placebo) | Experimental | Other: ACT-541468 placebo, Other: Ethanol 10%5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo |
| Treatment D (ethanol placebo + ACT-541468 placebo) | Experimental | Other: ACT-541468 placebo, Other: Ethanol placebo5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent prior to any study-mandated procedure.
- Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a reliable method of contraception, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential (i.e., postmenopausal).
- Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
Key exclusion criteria (9 listed)
- Pregnant or lactating women.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- Nicotine intake within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-541468One tablet of 50 mg ACT-541468 will be administered orally. | Drug | Treatment A (ethanol + ACT-541468), Treatment B (ethanol placebo + ACT-541468) |
| ACT-541468 placeboMatching ACT-541468 placebo will be administered orally as 1 tablet. | Other | Treatment C (ethanol + ACT-541468 placebo), Treatment D (ethanol placebo + ACT-541468 placebo) |
| Ethanol 10%Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L. | Other | Treatment A (ethanol + ACT-541468), Treatment C (ethanol + ACT-541468 placebo) |
| Ethanol placeboMatching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h. | Other | Treatment B (ethanol placebo + ACT-541468), Treatment D (ethanol placebo + ACT-541468 placebo) |
Primary outcome
Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation
Time frame: Several timepoints on Day 1; for up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 33205362Berger B, Brooks S, Zuiker R, Richard M, Muehlan C, Dingemanse J. Pharmacological Interactions between the Dual Orexin Receptor Antagonist Daridorexant and Ethanol in a Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Four-Way Crossover Phase I Study in Healthy Subjects. CNS Drugs. 2020 Dec;34(12):1253-1266. doi: 10.1007/s40263-020-00768-8. Epub 2020 Nov 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale Gasser study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-541468 and Ethanol 10% in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation (time frame: Several timepoints on Day 1; for up to 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.